Does the provision of a personalised oral health report including pictures aid patients in improving their gum health over a four week period?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: Randomisation Approximately 20 participants will be recruited to the study, with 10 participants assigned to each of the two possible treatment groups. Randomization will be at the patient level and executed through the Bristol Dental Clinical Trials Unit, according to a predetermined randomization schedule. Participants will be randomised by study staff to one of 2 treatment groups (Control group ‐ standard verbal oral health instructions (verbal OHI) or Test group – pictorial report + verbal oral health instructions (picture + verbal OHI) using a predetermined randomisation schedule. A unique screening number will identify each subject screened for study participation. Screening numbers will be assigned in ascending numerical order as each subject signs their consent form. Subjects who meet all inclusion and exclusion criteria will be randomised according to the randomisation schedule. Randomisation numbers will be assigned in ascending numerical order as each subject is determined to be fully eligible. The randomisation schedule will be generated via a computer‐generated system. For each patient recruited to the study, they will be required to attend 2 study visits with the research team. The appointments are as outlined below: Visit 1: (Approximately 40 minutes) • Consent • Oral hard and soft tissue examination • Eligibility • Patient assessment of standard mouth images with dentist to look at the appearance of healthy vs non‐ healthy mouths (See Appendix 3) • Intra‐oral scan of patient’s mouth and assessment of plaque – download report for patient to take away (Appendix 5) • Plaque and gingival health assessments (See Appendix 4) • Randomisation • Completion of questionnaire with regards to current oral health/hygiene practices (Part A CONDITION: Oral hygiene ; Oral Health ; Oral hygiene PRIMARY OUTCOME: ; At baseline and 4 weeks:; 1. Plaque levels measured using the O’Leary et al (1972) 2 point scale, ‘YES(1)’ or ‘NO (0)’; 2. Gingival health measured using a 5‐point MGI scale; 3. Bleeding on probing will be measured using a 2 point scale, ‘YES(1)’ or ‘NO (0)’; SECONDARY OUTCOME: ; At baseline and 4 weeks:; 1. Patient perceptions of the effectiveness of a having a pictorial report of their oral health as part of their dental care measured using questionnaire; 2. Patient attitudes to oral health measured at baseline and 4 weeks measured by questionnaire; 3. Participants’ understanding of gingival health vs gingival disease measured by questionnaire; 4. Assessment of the accuracy of the intra‐oral camera’s ability to assess plaque levels by comparison to traditional techniques (using dye); INCLUSION CRITERIA: 1. Aged 18 years and over, of either gender and in good health 2. Dentate with a minimum of 18 scorable teeth, with at least 4 teeth in the upper anterior sextant. 3. Without removable dental prostheses or fixed or removable orthodontic appliances 4. Willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form 5. Willing and physically able to carry out all study procedures 6. MGI score of =1 on at least one of the 2 identified teeth for assessment
Epistemonikos ID: 5f5f606ebfa222ec5f2af8c7a2edd94374899243
First added on: Aug 24, 2024